UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058640 |
|---|---|
| Receipt number | R000067059 |
| Scientific Title | Radiation Dose to Surgeon during Volar Locking Plate Fixation: A Comparison of Image Intensifier and Flat Panel Detector Systems |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 22:06:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Surgeon Radiation Exposure Comparison: Volar Locking Plate Surgery for Distal Radius Fractures
Acronym
Radiation Exposure Volar Locking Plate
Scientific Title
Radiation Dose to Surgeon during Volar Locking Plate Fixation: A Comparison of Image Intensifier and Flat Panel Detector Systems
Scientific Title:Acronym
FPD vs II Radiation Dose
Region
| Japan |
Condition
Condition
Distal Radius Fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the radiation exposure to surgeons' fingers during volar locking plate fixation using flat panel detectors (FPD) and image intensifiers (I.I.).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of radiation dose to the fingers and thyroid gland during surgery using recorded measurement data
Key secondary outcomes
Comparison of fluoroscopy times and radiation types.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgeons performing volar locking plate fixation for distal radius fractures.
Key exclusion criteria
Surgeons intervening in cases with patients having multiple fractures or following external fixation surgery, or those who fail to wear measurement badges correctly.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuzo |
| Middle name | |
| Last name | Honda |
Organization
Isahaya General Hospital
Division name
Orthopedic Surgery
Zip code
8540013
Address
24-1, Eishou-Higashimachi, Isahaya City, Nagasaki Prefecture
TEL
0957221380
crosscountry_yuzo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuzo |
| Middle name | |
| Last name | Honda |
Organization
Isahaya General Hospital
Division name
Orthopedic Surgery
Zip code
8540013
Address
24-1, Eishou-Higashimachi, Isahaya City, Nagasaki Prefecture
TEL
09049879729
Homepage URL
crosscountry_yuzo@yahoo.co.jp
Sponsor or person
Institute
Organization: Isahaya General Hospital
Division name: Orthopedic Surgery
Name:Yuzo Honda
Institute
Department
Personal name
Funding Source
Organization
No funding organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Isahaya General Hospital
Address
24-1, Eishou-Higashimachi, Isahaya City, Nagasaki Prefecture
Tel
0957221380
crosscountry_yuzo@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Background:
This study aims to provide detailed data on radiation exposure during volar locking plate fixation and contribute to the enhancement of healthcare worker safety. Specifically, the clinical utility of flat panel detectors (FPDs) versus image intensifiers (I.I.s) is evaluated.
Methods:
Analysis was conducted using patient data from previously conducted clinical trials, with approval obtained from the Medical Ethics Committee.
Significance:
This research proposes optimized surgical techniques and fluoroscopic systems to reduce long-term health risks associated with radiation exposure. It directly contributes to occupational health and safety for surgeons.
Subjects:
Data from 40 patients were utilized to compare flat panel detector (FPD) and image intensifier (I.I).
Limitations:
The study has certain limitations, including the need for further randomized trials and parameter adjustments.
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067059
